Exel Safety Huber Infusion Sets (20G and 22G sizes with Catalog Numbers 37854S, 37855S. 37858S).
This recall has been terminated (originally issued January 22, 2010).
- Company
- Exelint International Co.
- Recall Initiated
- December 23, 2009
- Posted
- January 22, 2010
- Terminated
- June 6, 2011
- Recall Number
- Z-0639-2010
- Quantity
- 3,360
- Firm Location
- Culver City, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Coring of port's septum, which may lead to: Decreased effectiveness of port, infection, necrosis, swelling, and embolization, which may result in Pulmonary Embolism, Limb ischemia, stroke, local extravasation of medication such as chemotherapy or other caustic material, may lead to local tissue necrosis, granulomas, failure to deliver therapy, need for additional surgery to replace implanted port
Distribution
US (VA TX NV KY OH NH MS NY OH NM DE WA AZ IL PA OR CO FL GA LA UT MI WI NV CA NJ MO IA) and Canada.
Lot / Code Info
Catalog 37854S Lot 09G31; Catalog 37855S Lot 09G31, Catalog 37858S Lot 09G31.
Root Cause
Device Design
Action Taken
Distributors have been advised to cease distribution of any recalled needles and infusion sets; to quarantine any remaining; to document amount on Customer Response Form; to return form to Exel (firm); to arrange for return of product to Exel for credit. Distributors also are advised to share recall notice with all affected customers. Contact phone: 727-827-1922x0 (M-F 9a-5p EST). Contact email: info@exelint.com